Lyme disease testing by large commercial laboratories in the United States.
Lyme disease testing by large commercial laboratories in the United States.
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DOI：
10.1093/cid/ciu397
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发表时间：
2014-09-01
期刊：
影响因子：
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通讯作者：
Mead PS
中科院分区：
文献类型：
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作者：
Hinckley AF;Connally NP;Meek JI;Johnson BJ;Kemperman MM;Feldman KA;White JL;Mead PS
实验室检测有助于评估疑似莱姆病 (LD) 患者。建议使用两层抗体测试方法，但也使用单层和未经验证的测试。我们对美国大型商业实验室进行了调查，以评估实验室实践。我们使用这些数据来估计检测成本和提交样本的患者中的感染数量。大型商业实验室被要求报告 2008 年全国范围内进行的检测类型和数量，以及四个 LD 流行州的阳性检测百分比。计算每种测试类型的总直接测试成本。已发表文献中提供的这些数据和测试特定性能参数用于估计源患者中的感染数量。七个参与实验室对全国约 240 万个样本进行了约 340 万个 LD 测试，估计成本为 4.92 亿美元。两级检测至少占所进行检测的 62%；替代检测占检测的比例不到 3%。提交样本的患者中估计感染频率为 10% 至 18.5%。就样本总数而言，2008 年估计有 240,000 至 444,000 名感染源患者。LD 检测很常见且成本高昂，大多数检测都是根据诊断建议进行的。这些结果强调了在出于诊断和监测目的解释实验室结果时考虑临床和暴露史的重要性。
Laboratory testing is helpful when evaluating patients with suspected Lyme disease (LD). A two-tiered antibody testing approach is recommended, but single-tier and non-validated tests are also used. We conducted a survey of large commercial laboratories in the United States to assess laboratory practices. We used these data to estimate the cost of testing and number of infections among patients from whom specimens were submitted. Large commercial laboratories were asked to report the type and volume of testing conducted nationwide in 2008, as well as the percent of positive tests for four LD endemic states. The total direct cost of testing was calculated for each test type. These data and test-specific performance parameters available in published literature were used to estimate the number of infections among source patients. Seven participating laboratories performed ~3.4 million LD tests on ~2.4 million specimens nationwide at an estimated cost of $492 million. Two-tiered testing accounted for at least 62% of assays performed; alternative testing accounted for less than 3% of assays. The estimated frequency of infection among patients from whom specimens were submitted ranged from 10% to 18.5%. Applied to the total numbers of specimens, this yielded an estimated 240,000 to 444,000 infected source patients in 2008. LD testing is common and costly, with most testing in accordance with diagnostic recommendations. These results highlight the importance of considering clinical and exposure history when interpreting laboratory results for diagnostic and surveillance purposes.